UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056672 |
|---|---|
| Receipt number | R000064773 |
| Scientific Title | The investigation of adherence to self-management using an pneumatic lymphatic drainage for lower limb secondary lymphoedema: A pilot study |
| Date of disclosure of the study information | 2025/04/15 |
| Last modified on | 2025/11/17 08:53:59 |
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Basic information
Public title
The investigation of adherence to self-management using an pneumatic lymphatic drainage for lower limb secondary lymphoedema: A pilot study
Acronym
Investigation of adherence to self-management of lower limb lymphoedema
Scientific Title
The investigation of adherence to self-management using an pneumatic lymphatic drainage for lower limb secondary lymphoedema: A pilot study
Scientific Title:Acronym
Investigation of adherence to self-management of lower limb lymphoedema
Region
| Japan |
Condition
Condition
Secondary lower limb lymphedema
Classification by specialty
| Hematology and clinical oncology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to investigate the adherence to self-management using PLD for secondary lower limb lymphoedema.
Basic objectives2
Others
Basic objectives -Others
Factors affecting the adherence to self-management using PLD for secondary lower limb lymphoedema.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adherence of a home Pneumatic lymphatic drainage
Key secondary outcomes
Demographic information (age, gender, height, weight, BMI, dominant hand)
Social background (employment status, household members)
Medical information (primary disease, side of lymphedema, symptoms associated with lymphedema, medical history , drug history, ISL stage, peripheral circulatory status)
Safety and tolerability (tolerability-limiting events, adverse events, deviations, usability)
Efficacy (lower limb circumference, QOL: J-LYMQOL-l, subjective assessment)
Other (physical activity : GPAQ, adherence of compression and weight management)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
This study will have participants implement self-management at home using a combination therapy that includes the use of PLD. PLD is a medical device that has been approved in Japan and is already in use in clinical settings. The following device will be used: Name: Sequential Air-Pressure Lymph Flow Promotion Device (PLD) Limiti (Technokatsura Co., Ltd.) Medical Device Approval Number: 30600BZX00129000 (Attached documentation will be submitted separately as an appendix) The PLD implementation protocol will be conducted as outlined below. Frequency: Once daily Duration: 30 minutes Intensity and compression direction: Optimal intensity determined by the physician prior to intervention Period: 2 weeks (outpatient visits must be scheduled within the range from 2 weeks after the start of intervention to 4 weeks after, with treatment continued until the day before the outpatient visit)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 35 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Outpatient with secondary lower limb lymphedema
2) Experience worsening of their lymphedema in the past 3 months
3) Age: 35 and 80 years
4) Consent to participate in this study
5) ISL stage II or III
Key exclusion criteria
1) DVT, thrombophlebitis, PE, or suspected these conditions
2) Ssevere arteriosclerosis or ischemic disease in the treated area
3) CHF
4) Possible negative effect by increasing blood flow to the heart
5) Weak bones (osteoporosis, etc.), a fracture or dislocation in the treated area
6) Acute inflammatory findings (dermatitis, cellulitis, etc.), severe skin disorders, ulcers, necrosis or gangrene in the treated area
7) Weak or unstable skin in the treated area, or recent skin graft
8) Sensory disorders in the treated area
9) Acute or chronic abdominal diseases, or Recent abdominal surgery
10) Muscle strain, torn fascia or muscle fibres, sprains or tendonitis in the treated area
11) Pregnancy
12) Patients who the doctor deems unsuitable for PLD use, such as those who cannot use it properly
13) Dementia, intellectual disability or suspected these conditions
14) Communicational difficulties with medical staff and maintenance staff due to language problems, etc.
15) Patients who have difficulty working with doctors during past medical treatment
16) Incapability of attending regular check-ups according to doctor requirement
17) Inpatients
18) Participation in a other clinical trial in the past 4 months
19) Severe peripheral neuropathy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Tsuji |
Organization
Keio University
Division name
School of Medicine, Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353633812
hiroki.okawara@keio.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Okawara |
Organization
Keio University
Division name
Department of Rehabilitation Medicine, School of Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353633812
Homepage URL
hiroki.okawara@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Hiroki Okawara
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kita Fukushima Medical Center
Kosei hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3879
med-rinri-jimu@adst.keio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
光生病院（岡山県）
北福島医療センター（福島県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 09 | Day |
Last modified on
| 2025 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064773
